Off-label use of medications in palliative care
All therapeutic substances in Australia are registered with the Australian Therapeutic Goods Administration (TGA). Off-label use describes use of a registered medication prescribed outside of its registered indication, dose, route or patient group. Off-label prescribing is common in palliative care (eg amitriptyline as an adjuvant analgesic, olanzapine for delirium or nausea, metoclopramide given subcutaneously).
Off-label prescribing is legal and acceptable in certain clinical situations. Prescribing may be reasonable if there is sufficient evidence of efficacy and safety (including broad clinical consensus) and the balance of benefits and harms for an individual has been assessed and found favourable. Consider off-label use only when all other options (including other registered medications) are unavailable, unsuitable, ineffective or not tolerated. If a medication is used off-label, the prescriber takes responsibility for monitoring its outcomes, effectiveness and adverse effects, and should be prepared to justify the use of the medication if required.
It may be necessary to obtain informed consent from the patient when using a medication off-label, and to provide them with additional written information, because the approved consumer medicines information leaflet will not include details about the off-label indications or use. Use of medications off-label is not subsidised by the PBS and therefore may be more expensive for the patient.
For more information on the quality use of off-label medications, see Rethinking Medicines Decision Making: Guiding principles for the quality use of off-label medicines (Council of Australian Therapeutic Advisory Group).